Face Recognition Task for Facial Disfigurement

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Epilepsy, Diabetes, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the proposed study is to use functional magnetic resonance imaging (fMRI) to investigate how a change in facial appearance is initially represented in brain circuits and then alters over time, as the new face becomes recognized as "me". Investigators will try to identify areas of the brain responsible for processing and storing information about self-facial recognition; Examine how these areas of the brain respond to images of "self" and "non-self" and; Investigate how the brain responds, over time, to changes in facial recognition, particularly at time points: i) prior to facial injury, ii) post-injury but prior to facial transplantation, and iii) after receiving facial transplantation.

Who Is on the Research Team?

Eduardo Rodriguez

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients with severe facial disfigurement approved for face transplantation. They must be able to undergo MRI scans, give informed consent, and perform the recognition task well. Excluded are those with metal implants, pacemakers, certain medical conditions like epilepsy or heart disease, mental illness history, claustrophobia, or who may be pregnant.

Inclusion Criteria

I have been approved for a facial transplant due to severe disfigurement.

Exclusion Criteria

I do not have epilepsy, diabetes, heart disease, thermoregulatory problems, and I am not pregnant or breastfeeding.

I do not have mental illness, claustrophobia, or neurological conditions that affect MRI quality.

Must be able to enter and be scanned using MRI.

Timeline for a Trial Participant

Pre-Transplant Assessment

Participants are imaged in the MRI scanner to assess brain activity in response to pre-injury and injured facial images.

1-2 weeks

1 visit (in-person)

Post-Transplant Imaging

Participants undergo functional MRI scanning at three points post-transplant to assess changes in brain activity in response to facial recognition.

Approximately 1 year

3 visits (in-person)

Follow-up

Participants are monitored for changes in self-facial recognition and brain activity over time.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Face recognition task

Trial Overview The study uses fMRI to explore brain activity related to self-face recognition after facial transplantation. It aims to pinpoint brain areas involved in recognizing one's own face and track changes over time before injury, post-injury/pre-transplantation, and post-transplantation.

How Is the Trial Designed?

Group I: Post-Transplant Time Point Experimental Treatment 1 Intervention

Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI). Patients for whom a pre-transplant fMRI was obtained will undergo functional MRI scanning at three-points post-transplant (approximately 2 and 4 months +/- 2 months post-operation and again at 1 year +/- 3 months post-transplant).

Group II: Pre-Transplant Time Point Active Control 1 Intervention

Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+